Progression of Diabetic Retinopathy Post Bariatric Surgery (BS)
| Tracking Information | |||||
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| First Received Date ICMJE | July 12, 2011 | ||||
| Last Updated Date | September 26, 2012 | ||||
| Start Date ICMJE | July 2011 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
rapid changes in the level of retinopathy [ Time Frame: 12 months ] [ Designated as safety issue: No ] whether rapid changes in the level of retinopathy do or do not occur in the transition period following surgery, where weight loss may be rapid causing improvement in insulin resistance and glycemic control. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01393873 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Progression of Diabetic Retinopathy Post Bariatric Surgery (BS) | ||||
| Official Title ICMJE | The Effect of Bariatric Surgery on the Progression of Diabetic Retinopathy | ||||
| Brief Summary | Studies conducted assessing diabetic eye disease have shown a progression of diabetic retinopathy with rapid improvement of glycemic control during pregnancy and in patients with type 1 diabetes. It is also well documented that bariatric surgery may result in rapid improvement of glycemic control in obese patients with type 2 diabetes. To our knowledge the progression of diabetic eye disease seen in pregnancy and type 1 diabetes has not been studied in obese type 2 diabetics undergoing bariatric surgery. To this end, this study will examine the effects of rapid glycemic control which is seen in type 2 diabetics following bariatric surgery on the progression of diabetic retinopathy. |
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| Detailed Description | Participants will be referred from the Department of Bariatric Surgery at NYU. The investigators plan to enroll 50 patients in this pilot study. A baseline eye exam will be conducted prior to surgery. Data, such as preoperative HbA1c level, weight, BMI, duration and control of diabetes, current medication regimen, and the grade of retinopathy will be noted. Study participants will have a baseline eye exam within three months of the scheduled surgery, followed by regular follow-up visits at 3 months, 6 months, 9 months, and 1 year. At each visit the following measures will be assessed: (1) weight, (2) blood pressure, (3) glycemic control as assessed by HbA1C, (4)level of retinopathy, and (5) visual acuity using the EDTRS acuity chart. The eye examinations will consist of a measure of best-corrected visual acuity, slit lamp examination to assess pressure, and a dilated funduscopic examination to determine the presence and/or level of retinopathy. The level of retinopathy will be characterized as: (0)None, (1) Mild, (2) Moderate, (3) Severe, and (4) Proliferative. In addition, the presence or absence of cystoid macular edema (CME) will be noted as (a) no CME or (b) CME present. At the initial visit, a baseline questionnaire will be given to participants to gather background information on demographics and pertinent medical history. During each follow up visit, an additional questionnaire will be given to monitor changes in factors such as medications, blood pressure, and weight that may occur after bariatric surgery. HbA1c measurements will be checked every 3 months in accordance with current standard of care recommendations. Due to established evidence of rapid improvement in glycemic control shortly after bariatric surgery, it is essential that the investigators have this lab data and perform funduscopic examinations at these intervals, to monitor improvement in glycemic control ascertain associations between changes in HbA1c levels and progression of retinopathy. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with type 2 diabetes in the bariatric service awaiting metabolic surgery for weight reduction/glucose control therapy. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Bariatric surgery pts with Type 2 DM
Primary bariatric surgery pts with Type 2 DM |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 2 | ||||
| Completion Date | July 2012 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01393873 | ||||
| Other Study ID Numbers ICMJE | R10-02084 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Heekoung A Youn, New York University School of Medicine | ||||
| Study Sponsor ICMJE | New York University School of Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | New York University School of Medicine | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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